FDA.reportPublic FDA data

Gelato Topical Anesthetic

Product NDC
68400-357
11-digit product format
684000357
Labeler code
68400
Product ID
68400-357_0bf0efac-c20b-5e3a-e063-6394a90a6d53
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-01
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gelato Topical Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 727988

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-357-30Gelato Topical Anesthetic30 g in 1 JARGEL307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-357GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]7Current NDC, Legacy NDC, 1 package rows20231208_80182c43-100f-4b15-a07e-819599ab9562.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN80182c43-100f-4b15-a07e-819599ab95627
727988Gelato Anesthetic 20 % Oral GelPSN80182c43-100f-4b15-a07e-819599ab95627
727988benzocaine 0.2 MG/MG Oral Gel [Gelato Anesthetic]SBD80182c43-100f-4b15-a07e-819599ab95627
238910benzocaine 0.2 MG/MG Oral GelSCD80182c43-100f-4b15-a07e-819599ab95627
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY80182c43-100f-4b15-a07e-819599ab95627
727988Gelato Anesthetic 0.2 MG/MG Oral GelSY80182c43-100f-4b15-a07e-819599ab95627
727988Gelato Anesthetic 20 % Dental GelSY80182c43-100f-4b15-a07e-819599ab95627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-357-306840003573030 g in 1 JAR (68400-357-30) 30 g2018-06-010000-00-00NoNoCurrent